Open to opportunities

Sangita Kondapalli

@sangitakondapalli

Regulatory Affairs Manager at Intuitive Surgical, who established a global regulatory intelligence framework for robotic surgery.

United States

Message

At Intuitive Surgical Inc., I led regulatory review and approval of global advertising, promotion, and training materials for Robotic Assisted Surgery systems. I also established a framework to monitor and implement global regulatory changes.

My work has spanned medical devices and biotechnology, from supplier quality audits and CAPA programs to quality systems and regulatory compliance. At Genomic Health Inc., I authored QMS procedures for ISO 13485:2016 certification and led implementation of Assurx CATSWeb.

Experience

Work history, roles, and key accomplishments

Senior Regulatory Affairs Manager

Intuitive Surgical Inc.

Oct 2019 - Mar 2026 (6 years 5 months)

Led regulatory review and approval of global advertising, promotion, and training materials for robotic-assisted surgery systems. Established a Regulatory Intelligence framework and served as Business Administrator for Veeva PromoMats.

Regulatory Affairs Advertising and Promotion Regulatory Intelligence Veeva Promomats User Acceptance Testing MedTech AdvaMed

Lead Supplier Quality Auditor

Stryker

Jul 2018 - Sep 2019 (1 year 2 months)

Served as Lead Auditor for global Mergers & Acquisitions, conducting onsite and desk audits to ensure seamless supplier integration. Managed supplier quality agreements, change control, and CAPAs for acquisition targets.

Supplier Quality Audits M&A CAPA Change Control Technical Quality Agreements

Senior Quality Assurance Engineer

Genomic Health Inc.

Mar 2017 - Jul 2018 (1 year 4 months)

Authored and implemented QMS procedures for ISO 13485:2016 certification and new product development for Oncotype DX tests. Led the implementation of Assurx CATSWeb software and served as the Lead for the global complaint handling process.

Quality Management Systems ISO 13485 CAPA CATSWEB Complaint Handling Product Development

CAPA Program Engineer

Abbott

Jan 2009 - Dec 2017 (8 years 11 months)

Managed end-to-end CAPA programs for Lasik equipment and Class III implantable devices. Reported site-wide quality metrics to Division and Corporate leadership, driving goals for NCR reduction and yield improvement.

CAPA Root Cause Analysis Risk Assessment Quality Metrics FDA Inspections NCR Yield improvement